Kornimate/medical-research-clean huggingface dataset:
postextubation use of noninvasive respiratory support in severely obese patients

Conditions: Obesity, Morbid; Extubation Failure

Summary: around 20% of the obese patients with higher body mass index (bmi) who are taken off the breathing tube and breathing machine (ventilator) end up needing it back to support breathing. the re-application of breathing tube is associated with poor outcomes, including high risk of pneumonia, longer hospital stays, and death. the purpose of this study is to assess if prophylactic use of noninvasive breathing support after removing the breathing tube lowers the chance of needing the breathing tube again.

patients with obesity are at risk of developing respiratory failure due to reduced lung volumes and chest wall compliance. obesity is one of the easily identifiable, contributing factors of extubation failure that often leads to prolonged mechanical ventilation use and icu stay. the early application of noninvasive respiratory support, especially niv, has been shown to reduce reintubation rates in obese patients in a small, non-randomized study. however, prolonged use of niv is often associated with decreased patient compliance and increased incidence of skin breakdown. hfnc is a noninvasive strategy that is comfortable, uses a nasal cannula and provides a high flow rate to meet the patient's inspiratory flow demand and thereby reduce work of breathing. the purpose of this rct will be to determine the effects of using niv alternating with hfnc for reducing the treatment failure rate compared with hfnc alone in extubated patients with severe obesity. we hypothesize that early, prophylactic use of niv alternating with hfnc will decrease the risk of respiratory failure (treatment failure) in severely obese patients.

Eligibility criteria:
inclusion criteria: 1. adult, age ≥ 18 years old 2. receiving invasive mechanical ventilation for ≥24 hours 3. bmi ≥40 kg/m2 4. undergoing planned extubation per treating team 5. arterial ph ≥7.35 or venous ph ≥ 7.31 within 30 mins of spontaneous breathing trial (sbt) exclusion criteria: 1. pregnant 2. use of extra-corporeal membrane oxygenation 3. chronic tracheostomy in place 4. unplanned or accidental extubation 5. terminal/compassionate extubation 6. contraindication to niv use 7. intubated because of an acute exacerbation of copd 8. underlying neuromuscular disease 9. no reintubation requested by patient/family 10. documented/known history of chronic hypercapnic respiratory failure on home niv (including bilevel pap). 11. enrolled in any other outcome study 12. treating clinician feels that hfnc or niv are either mandatory or contraindicated for a given patient
a proof of concept study to evaluate the dose response for the systemic benefit risk ratio of inhaled fluticasone propionate in chronic obstructive pulmonary disease

Conditions: COPD

Summary: chronic obstructive pulmonary disease (copd) is a major worldwide problem.steroids inhalers are now an established treatment for copd. inhaled steroids can have a number of bad effects including suppression of the adrenal glands because of absorption. a previous study in patients with copd. c-reactive protein (crp) is a peptide produced in the liver in response to inflammation. elevated circulating levels of crp are associated with heart conditions. high levels of crp have also been found in patients with copd. in some studies, steroid inhalers have reduced crp levels, and that of other inflammatory mediators, in patients with copd. it is unknown whether this reflects a reduction in lung inflammation or an effect of systemically absorbed corticosteroid. it is proposed to investigate the link between inhaled corticosteroid and serum crp, lung inflammation (measured by exhaled nitric oxide) and systemic absorption of steroids.


Eligibility criteria:
inclusion criteria: * current or ex-smokers * aged over 50years * fev1/fvc ratio \<0.7 * fev1\<80% predicted * improvement in fev1 following short acting beta-agonist not greater than 15% and 200ml. exclusion criteria: * diagnosis of asthma, bronchiectasis or abpa * inability to perform study procedures or give informed consent * known sensitivity to trial medications
reducing blood pressure in mid-life adult binge drinkers

Conditions: Alcohol Drinking; Binge Drinking; Blood Pressure; Alcohol Abstinence; Aging; Lifestyle Factors; Vasodilation; Behavioral Problem

Summary: this study has two phases: phase 1 is to examine blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers vs. alcohol abstainers/moderate drinkers. phase 2 is to examine the effect of 8-week aerobic exercise training on blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers

during phase 1, we will measure blood pressure, microvascular function, and sympathetic nerve activity (baseline assessment) in mid-life adult binge drinkers, alcohol abstainers, and moderate drinkers. only mid-life adult binge drinkers will enter phase 2 and be randomized to the exercise training group and non-exercise control group. after 8 weeks of intervention, we will re-measure blood pressure, microvascular function, and sympathetic nerve activity (post-intervention assessment) in mid-life adult binge drinkers.

Eligibility criteria:
inclusion criteria: * men and women (50-64 years of age) who do not drink alcohol, who drink at moderate levels, or who binge drink * female subjects will be postmenopausal (i.e., cessation of menses for ≥1 yr). * subjects who can speak and understand english. exclusion criteria: * a history of diabetes, cardiovascular disease, liver, or renal disease * current or history of smoking and illicit drug use * blood pressure ≥160/100 mm hg * other known traditional cardiovascular disease risks: obesity (bmi≥35 kg/m2), or hyperlipidemia (total cholesterol\>230 mg/dl and/or ldl cholesterol\>160 mg/dl) * active infection (in the past 2 months) * a history of seizures, cancer, or inflammatory disease (i.e., gout or rheumatoid) * unstable body weight (\>5% change during the past 6 months) * regular aerobic exercise training (i.e., they engage in 30 min of structured aerobic exercise at least 3 times per week) * current use of hormone replacement therapy (i.e., estrogen, progesterone, and testosterone)

Keywords: exercise training high-intensity interval training midlife adults middle-aged microvascular function sympathetic nerve activity
effects of trying to conceive using an home- or hospital-based ovulation monitoring on stress

Conditions: Fertility Issues; Stress, Psychological

Summary: the goal of this observational study is to compare the difference of stress level and anxiety and depression between couples under home ovulation monitoring and hospital ultrasound monitoring.and whether it has a negative effect on the couple's sexual behavior.the participants were all healthy couples with fertility requirements from the reproductive center of the first hospital of jilin university.the main questions it aims to answer are: * \[question1\] : does ultrasound monitoring of ovulation increase stress levels and anxiety and depression in couples trying to conceive? * \[question2\] : does ovulation monitoring affect couples' sexual function and satisfaction? participants will be asked to fill out questionnaires three times over four menstrual cycles.

the goal of this observational study is to compare the difference of stress level and anxiety and depression between couples under home ovulation monitoring and hospital ultrasound monitoring.and whether it has a negative effect on the couple's sexual behavior.the participants were all healthy couples with fertility requirements from the reproductive center of the first hospital of jilin university. each couple needs to complete three questionnaires, one after informed consent, the second after two menstrual cycles, and the third after four menstrual cycles. if the woman becomes pregnant within 4 cycles, the investigation will be stopped. the study was divided into two groups，home ovulation monitoring group and hospital ovulation monitoring group.the questionnaires used were the perceived stress scale (pss) , the hospital anxiety and depression scale (hads) ,sexual functioning was assessed with the female sexual function index (fsfi) ,the international index of erectile function (iief) and premature ejaculation diagnostic tool（pedt）.

Eligibility criteria:
inclusion criteria: * normal sexual activity, no contraception for more than six months, and no ovulation monitoring in any way before preparing for ovulation monitoring exclusion criteria: * couples with contraindications to pregnancy the man was diagnosed with severe oligozoospermia and azoospermia

Keywords: psychological stress ovulation monitoring anxiety depression sexual intercourse
regulation of hiit combined with iet on vascular function in young women with normal weight obesity

Conditions: Normal Weight Obesity

Summary: comparison of the effects of combined iet with hiit and hiit on vascular function in young nwo women.

this is a randomized clinical trial of single-blind with 3 arms (control group , hiit group and iet with hiit group), in which a pre-treatment-posttest design has been used.

Eligibility criteria:
inclusion criteria: * female, aged between 18 and 30 years old; * bmi between 18.5 and 24.9 kg/m2 with a bf% \> 30% (normal weight obesity determination criteria); * exercise capacity to complete the exercise programme. exclusion criteria: * acute or chronic musculoskeletal disorders, cardiovascular diseases, etc. that prevented training; * other diseases (such as diabetes, etc.) that had a great impact on physical condition; * bad habits (such as smoking, drinking, etc.); * and unstable body weight (up and down fluctuations of more than 2.5 kg) in the 3 months before the experiment.

Keywords: isometric exercise training high-intensity interval training normal weight obesity vascular fitness
nktr-102 in combination with cetuximab in patients with refractory solid tumors (phase 2a) and metastatic or locally advanced colorectal cancer (phase 2b)

Conditions: Tumor; Colorectal Cancer

Summary: study 07-pir-02 is a phase 2 study designed to evaluate the safety and efficacy of nktr-102 (peg-irinotecan) for the treatment of patients with colorectal cancer (crc). the study is comprised of two sequential components - phase 2a and phase 2b. the phase 2a portion is an open-label, dose-finding trial in multiple solid tumor types that are refractory to standard curative or palliative therapies. the primary endpoint of the phase 2a is to establish the /recommended phase 2 dose (rptd) of nktr-102 by measuring the frequency of dose limiting toxicity (dlt). the phase 2b portion is an open-label, randomized, two-arm study in patients with second-line metastatic colorectal cancer and study participants will be randomized (1:1) to receive either nktr-102 and cetuximab or irinotecan and cetuximab. the primary endpoint of the phase 2b portion of the trial is progression-free survival. secondary endpoints for both the phase 2a and 2b portion include response rate, response duration, overall survival, standard pharmacokinetics, and incidence of toxicities, including diarrhea and neutropenia.

the phase 2a portion of this study is completed. the following entries reflect the phase 2a portion of this study only. the phase 2b portion of the study was not enrolled. based on emerging data regarding the corresponding low efficacy of cetuximab in patients with kras mutations, as well as revised nktr-102 clinical development plans, the phase 2b portion of the study was not completed.

Eligibility criteria:
inclusion criteria: * male and non-pregnant, non-lactating female patients with an ecog performance score \<3 who have any type of solid tumor refractory to standard therapy and who have adequate bone marrow and organ function at screening. exclusion criteria: * patients must not have used any cyp3a4 inducers or inhibitors with 2 weeks prior to the first day of study drug treatment.

Keywords: phase 2a: multiple solid tumor types phase 2b: second-line colorectal cancer (crc)
ketogenic diet as protective factor during covid-19

Conditions: Covid19

Summary: the novel coronavirus disease (covid-19) is posing a serious challenge to the health-care systems worldwide, with an enormous impact on health conditions and loss of lives. more than 30 millions of recoveries worldwide were registered at the end of october 2020 with more than 1 million of deaths. as the disease continues to spread, strategies aimed to reduce hospitalization time in sub intensive unit care, thus reducing pressure on health system, but also to reduce some of the pathological features of covid-19 such as inflammation and the "cytokines storm". the ketogenic diet is a high fat, low carbohydrate, adequate-protein diet that promotes a physiological ketosis (due to an increase of liver ketone bodies production). high fat, low carbohydrate diets have been shown to reduce duration of ventilator support and partial pressure carbon dioxide in patients with acute respiratory failure. moreover, the physiological increase in plasma levels of ketone bodies exerts important anti-inflammatory and immunomodulating effects, which may reveal as precious tools to reduce potential adverse outcomes of covid-19 disease. the hypothesis of this study is that the administration of a ketogenic diet will improve gas exchange, reduce inflammation, and the duration of hospitalization. the plan is to enrol 28 patients with diagnosis of covid-19 hospitalized but not in icu with spo2 higher than 88%.


Eligibility criteria:
inclusion criteria: * patients hospitalized hospital with covid-19 diagnosis (nasopharyngeal and oropharyngeal swab) * peripheral oxygen saturation higher tha 88% exclusion criteria: * intensive unit care * under forced ventilation * peripheral oxygen saturation lower than 88% * parenteral nutrition

Keywords: inflammation cytokines sars-cov-2 ketogenic diet ketosis
evaluation of hand assessments in children with severe hand burns

Conditions: Burns

Summary: this study is designed to see if some tests of hand movement, strength, and function are valid for children with burns.

children will be given a battery of tests to determine the validity of these measures for children with severe hand burns. the tests include: * pinch and grip strength; * stereognosis; * speed of manipulation using the nine hole peg test, box \& blocks test, and the moberg pickup test; * measurement of range of motion of the wrist and fingers.

Eligibility criteria:
inclusion criteria: * third degree brns to one or both hands * all areas closed * age between 5 and 18 years old * english or spanish speaking exclusion criteria: * previous hand condition * unable to follow 2 step directions

Keywords: hand burns pediatrics
safety and efficacy study adding gsk2190915 to mid-dose inhaled corticosteroid/long acting beta agonist combination treatment for asthma

Conditions: Asthma

Summary: the primary objective of this study is to evaluate the efficacy and safety of adding gsk2190915 300mg or placebo tablets administered once daily to fluticasone propionate/salmeterol 250/50mcg inhalation powder administered twice daily in uncontrolled asthmatic subjects \> or = 18 years of age over the course of 6 weeks treatment. the secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily to fluticasone propionate/salmeterol 250/50mcg inhalation powder administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of gsk2190915 in uncontrolled asthmatic subjects \> or = 18 years of age over the course of 6 weeks treatment.


Eligibility criteria:
inclusion criteria: * age: 18 years of age or older * non-, former or current smokers with a documented smoking history of ≤ 10 pack years * asthma diagnosis as defined by the national institutes of health * best fev1 of 50% to \<80% of the predicted normal value * for current and former smokers, a post-albuterol fev1/fvc ratio of \>0.70 at visit 1/1a (between 5:00am and 12:00 noon) * ≥ 12% and ≥200ml reversibility of fev1 * must have been using fp/sal 250/50mcg inhalation powder bid for at least 2 weeks just prior to visit 1. * must be able to replace their current short-acting beta2-agonists with albuterol inhalation aerosol * must be able and willing to give written informed consent to take part in the study. * must be able and willing to comply with all aspects of the study including completion of daily e-diary. exclusion criteria: * history of life-threatening asthma * recent asthma exacerbation * concurrent respiratory disease * recent respiratory infection * liver disease * other concurrent diseases/abnormalities * oral candidiasis * drug allergy * milk protein allergy * immunosuppressive medications * administration of systemic, oral or depot corticosteroids within 12 weeks of visit 1 * oatp1b1 substrates within 4 weeks of visit 1 * cytochrome p450 3a4 (cyp 3a4) inhibitors * cytochrome p450 3a4 (cyp 3a4) inducers * investigational medications * compliance: any infirmity, disability, or geographical location which seems likely (in the opinion of the investigator) to impair compliance with any aspect of this study protocol * affiliation with investigator's site

Keywords: asthma gsk2190915
social cognition in huntington's disease: cognitive study and functional and morphological imaging

Conditions: Huntington's Disease

Summary: huntington's disease is a rare genetic neurodegenerative disease. it is accompanied by movement disorders, cognitive and behavioral. the social behavior of patients are changed, affecting interpersonal relationships. patients with huntington's disease are described as self-centered, lacking sympathy and empathy and mentally inflexible. these behavioral problems can be a major source of anxiety for patients and their families. these disorders also have a negative impact cognitive and motor symptoms as well as the functional abilities and the quality of life of patients and their entourage. authors have suggested that these problems could be related inter alia to social cognition disorders. this concept refers to a set of skills and emotional and social experiences that regulate relations between individuals and can explain the behavior of individuals and groups. the objective is to evaluate disorders of social cognition, which may account for behavioral changes in huntington's disease.


Eligibility criteria:
inclusion criteria: for all particpipants * patient gave its written consent * between 20 and 70 years * school level : at least 7 years * native language: french for presymptomatic patient * huntington's disease diagnosed with abnormal number of cag repeats: 36 \< nucleotide expansion (cag) * unified huntington disease rating scale moteur ≤ 5 for symptomatic patient * huntington's disease diagnosed with abnormal number of cag repeats: 36 \< nucleotide expansion (cag) * unified huntington disease rating scale moteur \> 5 exclusion criteria: * no national health insurance affiliation * being under guardianship * meeting brain mri exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body, renal failure, hypersensitivity of gadolinium) or refusing mri * pregnant or lactating women * patient with involuntary movement hampering the realization of mri
iua committee research project on the management of tasc c and d aortoiliac lesions

Conditions: Aortoiliac Atherosclerosis; Aortoiliac Occlusive Disease; Aortoiliac Atherosclerosis With Gangrene; Aortoiliac Atherosclerosis Without Gangrene; Aortoiliac Obstruction; Peripheral Arterial Disease; Peripheral Vascular Diseases

Summary: this study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type c and d by the transatlantic inter-society consensus (tasc ii

open surgery repair with aortobifemoral bypass (abf) remains the gold standard revascularization technique in patients with lifestyle-limiting intermittent claudication (ic) and chronic limb-threatening ischemia due to extensive aortoiliac occlusive disease (aiod), particularly in trans-atlantic inter-society consensus ii (tasc-ii) type d lesions the abf procedure has proven safe, effective, and durable, particularly considering its high long-term patency rates (85%-90% at five years and 75%-80% at ten years) despite its significant peri-operative associated morbidity (1). on the other hand, endovascular treatment (evt) offers an attractive alternative with durable results (four- or 5-year primary and secondary patency rates ranged from 60% to 86% and 80% to 98%, respectively), especially in less extensive aiod, while also providing less perioperative morbidity, making it generally preferable for patients with more severe comorbid conditions. thus, surgical approaches to extensive aiod have changed considerably over the last years, primarily due to increased evt, particularly with the uncovered aortoiliac stenting (ais). while tasc ii provides an anatomical framework to compare therapeutic techniques, the advancement of endovascular techniques has led to many trials suggesting that endovascular management of tasc ii c and d lesions is a potential alternative treatment to open strategies. it is attractive for patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to abf this study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type c and d by the transatlantic inter-society consensus (tasc ii).

Eligibility criteria:
inclusion criteria: * patients with peripheral arterial/atherosclerotic disease of the aorto-iliac sector undergoing direct, hybrid or endovascular surgical correction with transatlantic inter-society consensus (tasc ii) type d classification(12). * age \>18 years old exclusion criteria: * synchronous aortoiliac aneurysmatic/ectasic disease (aorta ap diameter \>25 mm)

Keywords: peripheral artery disease; aortobifemoral bypass; aortoiliac stenting; preoperative care;